Monitoring and managing vaginal health using advanced imaging technology
Continuous Monitoring and Management of Vaginal Health Via Multifunctional 1.7um Optical Coherence Tomography/angiography Endoscopy
This study is testing a new imaging technology to see how it can help women at different stages of menopause understand and manage their vaginal health better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 1 site (Irvine, California) |
| Trial ID | NCT04737616 on ClinicalTrials.gov |
What this trial studies
This study utilizes a novel Optical Coherence Tomography (OCT) and Optical Coherence Angiography (OCTA) endoscopy system to assess vaginal health in women across different menopausal stages. The research aims to evaluate the system's ability to capture changes in vaginal tissue integrity before and after menopause, as well as the effects of fractional-CO2 laser therapy on vaginal health. Participants will undergo a comprehensive assessment including questionnaires, pelvic exams, and OCT scans in a single visit. The study will enroll women classified as pre-menopausal, peri-menopausal, and post-menopausal, with a focus on those experiencing genitourinary syndrome of menopause.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older who are pre-menopausal, peri-menopausal, or post-menopausal.
Not a fit: Patients with a history of pelvic irradiation, current pregnancy or breastfeeding, recent hormone replacement therapy, or those unable to understand English may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of vaginal health in menopausal women, enhancing their quality of life.
How similar studies have performed: While the use of OCT technology in gynecological applications is emerging, this specific approach to monitor vaginal health in menopausal women is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria Aim 1: . Women who are premenopausal, peri-menopausal and postmenopausal Aim 2: . Postmenopausal women with genitourinary syndrome of menopause Exclusion criteria * history of pelvic irradiation * Current pregnant or breastfeeding * Use of hormone replacement therapy within three months of study enrollment * Inability to read and understand english * inability to follow research instructions
Where this trial is running
Irvine, California
- Beckman Laser Institute and Medical Clinic — Irvine, California, United States (Recruiting)
Study contacts
- Principal investigator: Felicia Lane, MD — UC Irvine
- Study coordinator: Linh Huynh, MPH
- Email: plhuynh@hs.uci.edu
- Phone: 714- 456-6155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.